Company
United StatesWakeMed IRB, Raleigh, NC – FDA Inspections
Inspection records and compliance data for WakeMed IRB in Raleigh, North Carolina. 3 FDA inspections on record, last inspected April 29, 2024.
Company Profile
This profile covers WakeMed IRB based in Raleigh, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected June 6, 2012. Last inspected April 29, 2024.
Most cited issue areas
- Initial and continuing reviews1 inspection
- List of members1 inspection
- Minutes of IRB meetings1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 29, 2024 | VAI | Biologics, Human Drugs, Medical Devices & Rad Health · Project Evaluation: Devices | 1237142 |
| December 8, 2016 | NAI | Human Drugs · Bioresearch Monitoring | 993732 |
| June 6, 2012 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 784930 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
WakeMed IRB
FEI Number
1049716
Address
3128 Smoketree Ct, Raleigh, North Carolina 27604, United States
Country
United States
ID: c233e7bb-e2af-4419-be44-36de8aa3353a